April Regulation Focus: Specialist vs. Generalist, IR, and More

Feature articles from April examined the roles of the regulatory specialist and generalist and the application of regulatory intelligence (RI) in managing the new European in vitro diagnostic medical device (IVDR) regulation, the development of an internal regulatory database in the context of oncology, and strategic planning. Also included are articles on options for fast-track regulatory pathways, selection of control groups in pediatric clinical trials, and the role of artificial intelligence (AI) in regulatory practice.

Keywords – career planning, generalist, pediatric clinical trials, regulatory watch, specialist

Specialist vs generalist

There is much debate among regulatory professionals about the merits of building a generalist skill set versus specialized skills. In Regulatory Specialist, Generalist or Generalist Specialist: Weighing the Options, Rupali Gupta, George Cusatis, and Darin Oppenheimer describe the respective roles and the difficulties in deciding between them during his career. The choice is rarely linear – career planning is fluid and constantly changing – but the authors provide a helpful step-by-step guide that takes specialist-generalist considerations into account when crafting a career trajectory.

Regulatory monitoring

One of RI’s main missions is to proactively identify regulatory changes and assess their impact on businesses. This ability to anticipate, prepare and react quickly in a difficult environment is crucial for the industry as it faces future health challenges and threats. In Managing the Challenges of the New IVDR: Lessons from the Pandemic, Raquel Carnero Gomez, details how RI can help medical technology companies assess the impact of the EU IVDR. The author examines how regulatory intelligence has helped device manufacturers manage regulatory changes during the pandemic and how lessons learned can help the industry assess and plan for the impact of the new legislative framework.

In Development of in-house regulatory database: solution for a competitive oncology landscape, Andrew Leung provides an overview of this development, with specific reference to the expanding oncology treatment setting. An interactive and targeted interface allows regulatory affairs users to access targeted content related to various oncology product programs. Additionally, in-house development means there are plenty of opportunities for direct feedback or suggestions to update or refine the system to better meet ever-changing organizational needs.

In strategic regulatory watch applications, Sapna Ghelani, Hemang Kotecha, George Cusatis and Darin Oppenheimer describe a three-part process of IR (data input, analysis, and output) and its strategic application to ensure continued business success throughout the product lifecycle. The authors introduce the different aspects of RI applications and provide helpful advice on each, including due diligence, strategy and policy as well as product planning and development, and post-market surveillance.

Pathway, pediatric and AI trials

Accelerated regulatory programs recognize the need for products targeting serious diseases with an unmet clinical need, such as COVID-19, to reach the market as quickly as possible and without the depth of evidence required for regular authorization. In Options and utility of the fast-track regulatory pathway: pandemic to endemic, Sarah A. Robinson, Alison R. Carter and David A. Brindley compare existing fast-track pathways in the US and EU and discuss COVID-specific regulatory programs that have been created in the past 2 years. They examine whether emerging regulatory lessons regarding COVID-19 products can be used to support drug development in persistent endemic and/or long-term development of non-COVID therapies.

In Considerations for Selection of Control Groups in Pediatric Clinical Trials, Josephine Dewhurst looks at different types of control groups and the specific challenges in designing pediatric trials. Selecting the most appropriate control arm can be critical to ensuring the success of a trial, as it can affect participant recruitment and retention, both of which are a challenge in pediatric trials because the population is small. The number of patients, the severity and progression of the disease, the ethical use of placebo, the use of off-label care and active controls, and the availability of data representative of the real world are among the considerations recommended by Dewhurst for ensure a feasible trial design.

As the demand for precision and rapid execution of regulatory tasks increases, technology is evolving to meet these new needs, including through the integration and actual application of AI. In Artificial Intelligence in Regulatory Practice, Zehra Mazhari examines how the regulatory profession can leverage AI and machine learning to navigate the complexities and fluidity of the global regulatory landscape.

Quote Matthews R. April’s Regulatory Focus: Specialist vs. Generalist, IR, and More. Regulatory Affairs. May 6, 2022. https://bit.ly/3kTLHwF

Coming in Regulatory guidance
What’s new in May?

May’s articles will provide an update on EU IVDR and MDR. Look for this topic and many more throughout May on Regulatory Focus. The deadline for submitting papers has been extended to May 16, 2022.

And June?

For the June issue, the subject will be Nutrition in health and disease management and the gut microbiome.

Call for papers
July issue

July’s theme will be Regulatory affairs mentorship. The deadline for submitting papers is June 1, 2022.

August issue
CMC [chemistry, manufacturing, and controls] regulatory issues is the subject of the August issue. The submission date for papers is July 1, 2022.

To contribute, email [email protected] See also 2022 Editorial Calendar

Coming in RF Quarterly

Each number of RF Quarterly is comprised of original content, developed around a theme, as an exclusive member benefit. The most recent issue, devoted to software as medical devices, is available.

The subjects until 2022 will be:

  • Regulatory History (June)
  • Regulatory Affairs Strategy (September)
  • Artificial Intelligence (December)

To contribute to these next issues, email [email protected]

Previous issues of RF Quarterly

For more information on monthly articles and RF Quarterlysee Author Guidelines and 2022 Editorial Calendar.

© 2022 Society of Regulatory Affairs Professionals.

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